Good afternoon. Welcome to the Anavex Life Sciences fiscal 2022 second quarter conference call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the session, if you would like to ask a question, please use the Q&A box or raise your hand. Please note that this conference is being recorded. The call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer. Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on the current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. With that, I would like to turn the call over to Dr. Missling. Thank you, Clint. We appreciate everyone joining us today conference call to review our most recently reported financial results and to provide a business update. We are pleased with the continued advancement regarding our lead product candidate, ANAVEX 2-73, in Alzheimer's disease and Rett syndrome, as we maintain our attention on execution across each of our clinical programs and overall business operations. In the second half of 2022, we are expecting two pivotal top-line results readouts, including top-line results from the randomized, placebo-controlled phase II-B/III study, ANAVEX 2-73-AD-004, for the treatment of Alzheimer's disease. From the randomized, placebo-controlled EXCELLENCE phase II/III study, ANAVEX 2-73-RS-003, for the treatment of pediatric patients with Rett syndrome. Next month, Anavex will host our R&D Day for investors and analysts on Tuesday, June 21, 2022. This R&D Day will include presentations from the company's leadership team with a focus on the company's clinical development pipeline. Additional details will follow closer to the event. In July, an oral presentation of effects of the sigma-1 receptor agonist, blarcamesine, ANAVEX 2-73, in a murine model of Fragile X syndrome, neurobehavioral phenotypes and receptor occupancy will be presented at the eighteenth NFXF International Fragile X Conference, July 14-17, 2022, taking place in San Diego, California. Further pipeline expansion of the Anavex platform using gene biomarkers of response, applying precision medicine for neurological disorders with unmet medical need is expected in 2022, including meeting with the FDA to discuss the ANAVEX 2-73 Parkinson's disease program, including a pivotal phase III study. Planned initiation of a ANAVEX 2-73 imaging-focused Parkinson's disease clinical study sponsored by the Michael J. Fox Foundation, and a planned initiation of a potentially pivotal phase II/III study in Fragile X, the most frequent genetic cause of autism spectrum disorder. Planned initiation of a phase II/III clinical trial for the treatment of a new rare disease indication. Planned initiation of ANAVEX 3-71 phase II clinical trial for frontotemporal dementia, schizophrenia, and Alzheimer's disease indications. Now, I would like to direct the call to Sandra Boenisch, Principal Financial Officer of Anavex, for a brief financial summary of the recently reported quarter. Thank you, Christopher, and good afternoon to everyone. During the quarter ended March 31, 2022, we continued to maintain fiscally responsible cash utilization as we expand and advance our pipeline. Our cash position at March 31, 2022 was $153.3 million, which we believe is sufficient cash runway to fund our operations and our clinical programs beyond the next four years. Our research and development expenses for the second quarter of fiscal 2022 were $8.6 million, as compared to $6.7 million for the same quarter of fiscal 2021. General and administrative expenses were $2.9 million, compared to $2.2 million in the comparable quarter of 2021. Overall, we reported a net loss of $10.4 million for the quarter, which is $0.14 per share. The overall increase compared to the previous year period is primarily related to an increase in non-cash compensation charges period-over-period, which is driven by the addition of staff to manage and support our clinical studies and development. Thank you, and I'll turn the call back over to you, Dr. Christopher Missling. Thank you, Sandra. We are looking forward to the next month's R&D Day events, where we will present our broad sigma-1 R platform portfolio, which allows us to expand further within the neurodegenerative and rare disease space. We remain on track to deliver data readouts as well as presentations at medical meetings and initiating biomarker-driven precision medicine clinical studies throughout the rest of the year as planned. I would like now to turn the call back to Clint for Q&A. Thank you, Christopher. We'll now begin the question and answer session. If you have a question, please raise your hand or enter it into the Q&A box. Our first call is coming from Yun Zhong at BTIG. Go ahead, Yun. Hi. Thank you very much for taking the question. On the pediatric Rett syndrome study, I see that the study has not completed patient enrollment, so I assume it's still ongoing. I wanted to confirm if you're going to put out a press release on patient enrollment completion. On the primary endpoint, is it reasonable to assume that it's still gonna be the AUC? Have you talked to the FDA? I believe the last guidance or last business guidance after the second data readout from the Rett syndrome was that you were going to talk to the FDA. Has that happened yet, please? Thank you for the call. Indeed. The last communication is that we are planning to meet the FDA to discuss the Rett program and its procedure to move forward with filing an NDA for approval. Since we finished and completed the AVATAR study in adults, a small study, despite the fact that it's a successful study, a phase II study which was also small, and the ongoing EXCELLENCE study, which is in pediatric study, which is the largest study. We are waiting for this meeting to take place. It has not yet taken place, but it will take place soon, and then we will learn how to move forward. Indeed, the Rett EXCELLENCE study with pediatric patients is still ongoing enrolling, and we might have a press release when the enrollment is completed. Well, with regard to the primary endpoint is still gonna be RSBQ AUC instead of... Right. ....RSBQ. That's right. When we presented AVATAR study, we learned from the first phase II study that the RSBQ AUC that includes the CGI-I-linked responder analysis. The RSBQ AUC includes the CGI-I-linked responder analysis. That is the endpoint which we will also propose for the EXCELLENCE study. That is correct. It's consistent with the AVATAR study. Okay. The second question is on the Parkinson's disease program. Can you remind us what you would like to achieve with the imaging study? Do you need to talk to the FDA before you initiate that imaging study? It's a good question. The goal is to show what we have already seen with the anecdotally, that the sigma-1 is a completely clearly dose-dependent target engaging the sigma-1 receptor in the brain, and that is an additional confirmation in humans, and among them also in Parkinson's patient. That's why we were able to receive the full support, non-dilutive funding as a grant from the Michael J. Fox Foundation for this study. We probably will very likely use that opportunity to meet also with the FDA to discuss the Parkinson's program in its totality, including the phase three, which we said we are happy to move forward with given the successful phase II PDD study. Okay. Great. Thank you very much, and we look forward to the R&D Day in June. Thank you very much. Thank you. The next call is from Pete Stavropoulos from Cantor. Go ahead, Pete. Pete, I think you're muted. Hi, Christopher. How are you? Good. How are you? Good. Thank you. I don't know if I've missed it in the previous question, but I know that you haven't spoken to the agency recently. But from previous discussions, do you have a sense of whether or not you're gonna need to wait for the pediatric data to file for the adult indication? The pediatric data is a larger study, and in theory, if you would file for adults you would not need it because it's a different age group. What we believe is probably a prudent assumption is to include the pediatric study in its totality for the Rett program. As we stated, we don't know that yet until we meet the FDA for guidance on how to move forward in terms of regulatory filing for approval of ANAVEX 2-73 for Rett syndrome. All right. Thanks. Thank you for the clarification. I also wanted to ask about your thoughts regarding sort of the lessons, the takeaways from the Rett syndrome experience with 2-73 and their applicability to potentially, you know, clinical development initiatives with the compound, say, in Fragile X. If you could give us, you know, a sense of when you anticipate the Fragile X program to initiate patient enrollment. Right. We are very excited about the Fragile X program for two reasons. First of all, we have very solid, and it is a very strong evidence animal model in Fragile X, which was published last year. There's new data coming out, and among them it will be presented also at the conference in July, which we pointed out. There will be additional biomarker information, making very clear of pathology, biomarker pathology, making clear that the drug really improves the phenotype of this disease, which is the largest autism spectrum disorder. Why it's exciting for a second reason is because this largest autism spectrum disorder is like Rett syndrome, the autism under the autism spectrum disorder and we measured the ADAMS score, which is a key measure of anxiety, which is a known feature of or limitation and problem for these patients with autism. We were very successful in both Rett studies in the phase II and in the phase III AVATAR to the successful improvement with the drug on this endpoint of the ADAMS score. That is why we're very excited, both from the preclinical data as well as from the clinical data side of point of view. What we are now doing, we want to make sure that the protocol is very robust, because the challenge of Fragile X, it's a very diverse patient profile. There are very different features of the disease which are not similar. We want to make sure we are using a population, a trial population, which is as homogeneous as possible so in order to avoid a trial failure, because not the drug doesn't work, but because the patients are so different and the endpoints you selected for these patients don't apply to all. It is a key what we are now in the process of figuring out. We will meet with the agency and confirm that approach and also make sure that we can run this as a pivotal study. We expect this to take place in the second half of this year. At the same time, will you be also consulting with the EMA or that'll be at a later time point? That's right. Since we will include most likely also pediatric patients, we will also include the discussion with EMA, which is important because they want to be also, have a discussion before that trial starts. Okay. Just one last question on the Alzheimer's program. Can you provide any type of color on the rollover rate, you know, from the phase II-B/III into the open-label extension? Yeah. The last I heard was there was over 90% rollover from patients who finished the placebo-controlled study in the open-label extension, so that's a very positive sign. We're very excited because we're getting really close to finishing the study of the last patient out, and then we can start the process of data cleanup as well as then locking the database and then subsequent releasing the data. We're very excited about this. Excellent. Thank you very much for taking our questions. Thank you, Pete. The next question is, I'm guessing from Soumit Roy at Jones Trading. Hi, this is Soumit Roy here. Okay, great. Sorry. Congrats on all the progress. Question on the Alzheimer's front. Could you give us a little finer detail on when should we think the data to come out? Is it still third quarter or fourth quarter? It's a good question. Since we said second half, I like to stick to that because we don't know exactly how long the data cleanup takes, and it's quicker done, performed, then it might be in Q3, and if it takes longer, then it will be just slipping into Q4. It's best really to call it second half 2022. When we have more clarity, we'll provide a closer update. Was that the only question? Thank you for taking the question. That's all. Thank you. Great. Thank you. I have one question from Muz Saleem from H.C. Wainwright. He said, "What are the key points of the agenda for your upcoming meeting with the FDA with the Parkinson's disease program pivotal study? For example, will a biomarker endpoint be pushed up in priority owing to your recent success with sigma-1 mRNA expression data in phase II? This will be all on the agenda, and since we are sharing this data very timely now, and we wanna also make sure we are able to include the extension data of the Parkinson's study. Since this is now completed, and once we have that, we will be able to have a bigger picture of the Parkinson program, and the items you just referred to will be all discussed. Okay. A second question from Muz is, can you give us a preview of the new indication that you're excited about in the neurodegenerative and rare disease space... Mm-hmm ...that you'll be showcasing at your upcoming R&D Day event? Right. We will have the ability to choose between several rare disease indications, and that's why we have it kept like that. It really shows the worth and the value of the platform we have, and it's backed by preclinical data on different indications. We wanna make sure we are doing or prioritizing the right rare disease if we are comfortable with the clinical design to show efficacy. That's really what we're working on. That's why we didn't mention what indication it is, but there are different indications, separate indications, independent indications which could become the indication which we will release once the trial starts, and it's only because we have the ability to showcase several rare disease indications being demonstrated positively impacted by the drug ANAVEX 2-73 in respective clinical animal models. Muz, I see you're in the chat now. You can go ahead and ask your own questions. Perfect. Thanks. Yeah, I'll save you some trouble. Hi Christopher, thanks for taking our questions. In terms of your upcoming ANAVEX 2-73 imaging-focused Parkinson's study, we were wondering if you collected imaging data from the phase II trial, and if you did, could this methodology from your current study be used to combine the data? If I might ask, combine the data with what exactly? If you may have collected imaging data in the phase II trial, or you did not collect any imaging. Yeah, we did not. In the phase II, Parkinson's disease dementia study, there were no imaging study collected, and that's why this imaging study separately is now taking care of that. Okay. Understood. In terms of ANAVEX 3-71 for AD, will you use the same cohort characteristics, or do you think this drug could potentially differentiate from ANAVEX 2-73 and be more efficacious in certain subpopulations of AD patients? That's an excellent question. We're expecting that there will be some additional data on ANAVEX 3-71 preclinically also to give us guidance on this, to fine-tune the indication. Right now, without any further, you know, knowledge on this, it could be the best choice for going into patients with AD which have the best, I would say, cohort consistency and homogeneity to, and also availability to make the trial as, you know, robust and as quick as possible in its enrollment. This will be more likely the early Alzheimer's disease patients similar to what the phase III of the ANAVEX 2-73 study is right now. Okay. Understood. Just finally on ANAVEX 3-71, we're looking forward to this one. Could you expound briefly on the strategy for the three indications for this program? Clearly FTD appears to be a front-runner here. How confident are you in the schizophrenia indication, given the sigma-1 receptor activation has been associated with off-target effects and psychosis? Yep. We actually were very excited because ANAVEX 3-71, as a reminder to everyone, is not only a sigma-1 agonist but also an M1 agonist. There are trials out now which has been shown to be very successful in this indication of schizophrenia with pure M1 agonists. If you now look at what we heard from the inventor of ANAVEX 3-71, who always told us that he looked at M1 agonist as a target, and he found by accident, so to speak, ANAVEX 3-71 being more potent than all the other previous drugs he had developed as M1 agonist. We looked at the profile of this ANAVEX 3-71 molecule, he saw that there was not only M1 agonism, but also sigma-1 activity. He postulates that ANAVEX 3-71 in schizophrenia would be even more proactive and successful, possibly because of the sigma-1 activity. That's why we're excited about the ANAVEX 3-71 in schizophrenia as well. Okay. Brilliant. Thanks for taking our questions. Good luck this year. Thank you very much. Yun, it looked like maybe you had a follow-up question. Yeah. Thank you very much for taking the follow-up question. Yeah, it looks like you have a lot of milestones planned for the second half of this year. I wonder, you know, I'm now questioning the capacity to be able to complete all the milestones. Seems a lot of activities. If you have to talk about the priority, which one do you think could be the most important one that you think for the pipeline development? I think it's really consistent with the bullet points you have seen today. It's really finishing the Alzheimer's study, which is in autopilot, so we just have to, you know, do the clean-up work, if you so like, and the same as finish the Rett study. Following with the priority, I think it would go into Fragile X study, given that's a relatively short study and can be pivotal potentially, and it's a huge unmet need, and it's seven times the size of Rett syndrome in terms of indication number of patients. Also following up with the Parkinson's disease pivotal study. Also, I would not rule out frontotemporal dementia and also schizophrenia, especially schizophrenia for ANAVEX 3-71. When I say frontotemporal dementia, I mean for ANAVEX 3-71, because schizophrenia is relatively short study, and that obviously would be important to that. Also, I don't want to forget to mention the rare disease which we have not yet given a name for the indication and to do a pivotal study in that indication. You know, really consistent with the bullet points you have seen. Okay. Great. Thank you for the confirmation. Thank you. Looks like we may have a follow-up question from Pete as well. No, maybe not. Christopher, I think that I have no further questions at this time, so you can continue. Thank you very much. Again, to reiterate, we are looking forward into the remainder of 2022, and we're very excited about the company's potential platform, especially as we build on successful completion of two important biomarker-driven precision medicine pivotal studies, and we're looking forward to these pivotal clinical readouts in Alzheimer's disease and Rett syndrome. We are very excited to move forward with the planned studies, which we really want to initiate because of its unmet need, and we're very excited about this. Look forward to updates and reach out to us for questions. Clint? Thank you, Christopher. Ladies and gentlemen, that concludes the call today. Thank you for participating, and you may now disconnect.